A Randomized Phase 2 Study of Ocular Toxicity Evaluation and Mitigation During Treatment with Mirvetuximab Soravtansine in Patients with Recurrent Ovarian Cancer with High Folate Receptor-Alpha Expressio

Phase 1

• Conditions: Recurrent Ovarian Cancer with High Folate Receptor-Alpha Expression; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2023-505617-24-00
• Lead Sponsor: Immunogen Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-21
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 87

Inclusion Criteria

Patients = 18 years of age, Patients must have completed any major surgery = 4 weeks prior to first dose of MIRV and have recovered or stabilized from the side effects of prior surgery prior to first dose of MIRV., Patients must have adequate hematologic, liver, and kidney functions defined as: a. Absolute neutrophil count (ANC) = 1,000 cells/µL without granulocyte colony stimulating factor (G-CSF) in the prior 10 days or long-acting white blood cell (WBC) growth factors in the prior 20 days; b. Platelet count = 100 × 109/L (100,000 cells/µL) without platelet transfusion in the prior 10 days; c. Hemoglobin = 8.0 g/dL without packed red blood cell (PRBC) transfusion in the prior 7 days d. Creatinine clearance (CrCl) = 30 mL/min per the Cockcroft-Gault formula; e. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 3.0× ULN; f. Serum bilirubin = 1.5 × ULN (patients with documented diagnosis of Gilbert syndrome are eligible if total bilirubin < 3.0 × ULN); g. Serum albumin = 2 g/dL, Patients must be willing and able to sign the informed consent form (ICF) and to adhere to the protocol requirements, Women of childbearing potential (WOCBP) must agree to use highly effective contraceptive method(s) while on MIRV and for = 7 months after the last dose., WOCBP must have a negative pregnancy test = 4 days prior to the first dose of MIRV, The following requirements are for patients who are human immunodeficiency virus (HIV) positive: a. On established highly active antiretroviral therapy (HAART) for = 12 weeks with an HIV viral load of less than 200 copies/mL, HAART is a requirement for the duration of the study. The specific agents are at the discretion of the investigator; b. Cluster of differentiation 4 (CD4+) T cell counts = 400 cell/µL; c. No acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection within the past 12 months, Patients must have an Eastern Cooperative Oncology Group Performance Status (ECOG-PS) of 0 or 1, Patients must have a confirmed diagnosis of epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer (collectively referred to as EOC hereafter) with high FRa expression, Patient's tumor must be FRa positive (FRa high) as defined by either the Ventana FOLR1 (FOLR1-2.1) CDX Assay or Ventana FOLR1 (FOLR1-2.1) RxDx Assay (hereafter collectively termed: Ventana FOLR1 Assay) (=75% cells exhibit 2 or 3+ membrane staining intensity), Patients must have recurrent ovarian cancer that may be platinum-resistant or platinum-sensitive as defined below). - Platinum-sensitive disease: a. Patients with platinum-sensitive disease are defined as radiographic progression = 6 months from the last dose of the most recent platinum therapy; b. Patients’ disease must have progressed radiographically on (non-platinum only) or after their most recent line of anticancer therapy. - Platinum-resistant disease: a. Patients who have only had 1 line of platinum-based therapy must have received = 4 cycles of platinum, must have had a disease response (complete response [CR] or partial response [PR]), and then had disease progression > 3 months and = 6 months after the date of the last dose of platinum; b. Patients who have received 2 to 4 lines of platinum therapy must have progressed during or = 6 months after the date of the last dose of platinum; c. Patients with primary platinum-refractory disease (disease progression = 3 months from last dose of platinum of first line of treatment) will n

Exclusion Criteria

Patients with borderline ovarian tumor or non-epithelial histology or mixed histology including these borderline or non-epithelial histology will be excluded, Patients with clinically significant comorbid conditions, including, but not limited to, any of the following: a. Myocardial infarction = 6 months prior to first dose; b. Unstable angina pectoris; c. Uncontrolled congestive heart failure (New York Heart Association > Class II); d. Uncontrolled = Grade 3 hypertension (per NCI-CTCAE v5.0); e. Uncontrolled cardiac arrhythmias; f. Patients with a history of hemorrhagic or ischemic stroke = 6 months prior to enrollment; g. Patients with a history of cirrhotic liver disease (Child-Pugh Class B or C); h. Patients with a previous clinical diagnosis of noninfectious interstitial lung disease (ILD), including noninfectious pneumonitis; i. Patients with medical conditions requiring use of folate-containing supplements (eg, folate deficiency)., Patients with prior hypersensitivity to monoclonal antibodies (mAbs), Patients who are pregnant or breastfeeding, Patients who received prior treatment with MIRV or other FRa-targeting agents, Patients with untreated or symptomatic central nervous system metastases, Patients with a history of other malignancy = 2 years prior to enrollment, Patients with a prior known hypersensitivity reaction to study drugs or any of their excipients, PROC patients with primary platinum-refractory disease, defined as disease that did not respond to (CR or PR) or progressed = 3 months of the last dose of first line platinum-containing chemotherapy, Patients with prior wide-field radiotherapy (RT) affecting = 20% of the bone marrow, Patients with > Grade 1 peripheral neuropathy per National Cancer Institute-Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0), Patients with significant active or chronic corneal disorders (eg, corneal dystrophies, degenerations, limbal stem cell deficiency), history of corneal transplantation, significant ocular inflammatory conditions (eg active or recurrent uveitis), or other active ocular conditions requiring ongoing treatment/monitoring, such as uncontrolled glaucoma, active diabetic retinopathy with macular edema, macular degeneration requiring treatment = 90 days prior to first dose, presence of papilledema, BCVA worse than 20/70, or monocular vision, Patients receiving corticosteroid or vasoconstricting eyedrops at baseline or within 5 weeks of C1D1, Patients who are ineligible to receive either brimonidine or corticosteroid eye drop, Patients with serious concurrent illness or clinically relevant active infection, including, but not limited to the following: a. Active hepatitis B or C infection (whether or not on active antiviral therapy); b. HIV infection (if inclusion criteria #15 is not met) c. Active cytomegalovirus infection; d. Any other concurrent infectious disease requiring intravenous (IV) antibiotics = 2 weeks prior to the first dose of MIRV, Patients with a history of multiple sclerosis or other demyelinating disease or Lambert-Eaton syndrome (paraneoplastic syndrome).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified